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Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D

NCT03099785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2021-01-08

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered two to three times daily.

Conditions

  • Diarrhea-predominant Irritable Bowel Syndrome

Interventions

DRUG

Rifamycin SV 600mg t.i.d.

Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet

DRUG

Rifamycin SV b.i.d. + Placebo

Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet

DRUG

Placebo t.i.d.

Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet

Sponsors & Collaborators

  • Cosmo Technologies Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2020-09-11
Completion
2020-12-14

Countries

  • Belgium
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099785 on ClinicalTrials.gov